St. Jude Riata Lead Lawsuits Not Pre-Empted, Federal Judge Rules

A federal judge has cleared the way for St. Jude Riata defibrilator lead lawsuits to move forward, rejecting an argument by the manufacturer that they should be shielded from liability in the cases under the theory of federal preemption.

Earlier this month, U.S. District Judge James V. Selna, in the Central District of California, denied a motion to dismiss (PDF) filed in five product liability lawsuits filed on behalf of individuals who experienced problems from St. Jude Riata leads, which were removed from the market amid reports that the insulation may fail after they are implanted.

Attorneys for St. Jude have maintained that they should not be held responsible for injuries caused by the leads, arguing that such claims are preempted by federal law since the medical device was approved by the FDA. However, in an order issued January 9, Judge Selna found that the claims either paralleled federal requirements or were based on alleged violations of FDA regulations. The judge also rejected arguments that plaintiffs had failed to show a plausible link between their injuries and the leads.

The St. Jude Riata and Riata ST ICD leads are small wires used to connect an implantable cardiac defibrillator (ICD) to the heart. They were removed from the market in late 2010 amid reports that suggested the insulation surrounding the leads was prone to fail, resulting in exposed wires inside the body. This could result in unnecessary shocks or cause the defibrillator to fail to deliver a life-saving jolt when needed, often requiring revision surgery to remove the lead once problems are detected.

The manufacturer issued a warning to doctors in late 2011 about reports of insulation problems, and the FDA later determined that the action qualified as a St. Jude Riata recall.

Approximately 227,000 St. Jude Riata wires were sold worldwide before it was removed from the market, and estimates suggest that approximately 79,000 of the leads remain active in patients in the United States, as the process of attempting to remove the lead is very risky and doctors usually recommend keeping the recalled lead in place unless there is evidence that it has failed.

In August 2012, the FDA issued a safety communication in response to concerns among individuals who still have one of the recalled St. Jude Riata or Riata ST leads, recommending that individuals undergo x-ray or other imaging exams to monitor the condition of the leads.

St. Jude faces a number of similar product liability lawsuits brought in courts throughout the country, which allege that the manufacturer designed and sold an unreasonably dangerous and defective product.